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Based on interview and record review the facility failed to document pain assessment for:

1. Patient N701 after being given pain medication as per policy and procedure.

2. Patient N404.

3. Patient N200 upon admission

4. Patient N200, Patient N201, Patient N202, Patient N203, Patient N204, and Patient N205 after pain management interventions.

5. Patient N501 and Patient N503.

These failures had the potential for patients pain to be not properly assessed and addressed resulting to inadequate pain control.


Findings:


1. During a concurrent interview and record review on 11/4/21 at 9:23 a.m., with nurse manager (NM1), Patient N701 was given Tylenol 1000mg Intravenous (IV via veins) on 11/3/21 at 12:21 a.m., for abdominal pain rated 7/10 at 12:25 p.m. No documentation of pain reassessment was located in the patient's medical record before (pre) and after (after) the IV medication administration. The NM1 acknowledged pain reassessments were not documented and should have been.

During a review of the facility's policy and procedure titled, "Pain Management", dated 2/18, indicated in part ... "B: Reassessment ...1. Pain reassessment will occur once per shift, after pain management interventions, and according to the individual needs of the patient ...2. Reassessment will include at least the following: a. intensity/level of pain (pain scale number) ...b. location ...c. sedation level when opioids are in use ... 3. Document the reassessment ...C: Pain scale-assess/reassess the patient's pain intensity and goal for relief using one of the scales below: numeric scale (0-10) ...no pain=0, mild pain= 1-3, moderate pain=4-6, severe pain= 7-10."


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2. Facility policy review on 11/2/21 titled "Pain Management" revised 2/21/18, indicated, "F. Documentation:1. The following information will be documented in the appropriate areas of the patient's medical record ... pain assessment and reassessment."

During a review of Patient N404's clinical record and concurrent interview with three North Manager (3NM) on 11/02/21, at 12:28 p.m., the physician order of Morphine 2 milligrams (mg) via intravenous push (IVP) as needed for severe pain (scale 7/10) was reviewed. The medication administration record (MAR) indicated Morphine 2 mg IVP was administered to Patient N404 on 11/1/21 at 10:40 a.m., for 7/10 pain. No assessment for pain was located in the MAR post IVP administration . 3NM confirmed post assessment documentation should have been done and documented .


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3. During a concurrent interview and record review on 11/1/21, at 3:00 p.m., with licensed nurse (LN 6), Patient N200's "Labor Flowsheet" dated 10/30/21, was reviewed. The "Labor Flowsheet" indicated Patient N200 was first observed in labor and delivery at 11:18 p.m. A first set of vital signs were taken. The pain evaluation was blank. LN 6 acknowledged there was no pain evaluation documented and there should have been. During further review of the "Labor flowsheet", Patient N200 was admitted to labor and delivery on 10/31/21 at 1:14 a.m. The pain evaluation was blank. LN 6 acknowledged no pain evaluation was documented and further verbalized a pain assessment should be documented upon admission.

During a review of the facility's policy and procedure titled, "Pain Management", dated 2/18, indicated in part ... "It is the policy of Adventist Health Simi Valley to deliver prompt and effective assessment, diagnosis, and treatment of pain using a collaborative interdisciplinary approach with participation of the patient and the patient's family/significant others ...procedure: A- initial/first patient assessment ... 1 ...screen patient for pain-is the patient in pain now? 2 ...if yes to above, assess for the following, and document appropriately. Accept the patient's description of his/her: a: intensity/level of pain ... b: location of pain ... c: duration/frequency of pain ... d: quality of pain ... e: onset of pain ...f: aggravating/alleviating factors ...g: relief measures used/interventions."

4. During a review of the facility's "Patient Guidebook" undated, indicated in part ... "Patient Rights: you have the right to: 9. Appropriate assessment and management of your pain, information about pain, pain relief measures and to participate in pain management decisions."

During a concurrent interview and record review on 11/1/21, at 3:05 p.m., with licensed nurse (LN 6), Patient N200's "Labor Flowsheet" dated 10/31/21, was reviewed. The "Labor Flowsheet" indicated Patient N200 received an epidural (a procedure when an anesthetic medication is injected into your lower back to control pain during childbirth) at 2:38 a.m. The pain evaluation was blank. LN 6 acknowledged there was no pain evaluation documented after the epidural placement and there should have been. The "Labor Flowsheet" further indicated Patient N200 delivered the baby at 5:00 a.m. on 10/31/21. The first pain evaluation that was documented, in the "Labor Flowsheet", was at 5:20 a.m., after the baby was born.

During a concurrent interview and record review on 11/1/21, at 3:07 p.m., with LN 6, Patient N200's "Medication Administration Record (MAR)" dated 10/31/21 was reviewed. The MAR indicated on 10/31/21 at 4:20 p.m., Patient N200 pain was assessed to be a three out of 10 (using the numeric scale 0-10, no pain=0, mild pain=1-3, moderate pain=4-6, severe pain= 7-10). Patient N200 was given Acetaminophen-Hydrocodone 5-325mg tablet (narcotic used to treat pain) at 4:20 p.m. At 5:20 p.m., an hour later, the pain response on the MAR was left blank. The MAR indicated Patient N200 was also given Ibuprofen 600 mg tablet (medication to treat pain and inflammation) at 4:20 p.m. At 5:20 p.m., the pain response on the MAR was also left blank. LN 6 acknowledged Patient N200's pain reassessments were not documented and should have been. LN 6 further verbalized pain should be reassessed an hour after pain medication administration.

During a concurrent interview and record review on 11/1/21, at 3:12 p.m., with LN 6, Patient N201's MAR dated 10/31/21 was reviewed. The MAR indicated on 10/31/21 at 6:02 p.m., Patient N201 pain was assessed to be a 5 out of 10. Patient N201 was given Acetaminophen-Hydrocodone 5-325mg, two tablets, at 6:02 p.m. At 5:20 p.m., an hour later, the pain response on the MAR was left blank. LN 6 acknowledged Patient N201's pain reassessment was not documented and should have been.

During a concurrent interview and record review on 11/3/21, at 2:42 p.m., with the labor and delivery manager (Peri-OpD), Patient N202's MAR dated 10/8/21 was reviewed. The MAR indicated on 10/8/21 at 7:59 p.m., Patient N202 pain was assessed to be a two out of 10. Patient N202 was given Ketorolac 30 mg (medication to treat pain and inflammation) IV (in the vein) at 7:59 p.m. At 8:59 p.m., an hour later, the pain response on the MAR was left blank. Patient N202's MAR dated 10/10/21 was reviewed. The MAR indicated on 10/10/21 at 6:37 a.m., Patient N202 pain was assessed to be a two out of 10. Patient N202 was given Ibuprofen 600 mg tablet at 6:37 a.m. At 7:37 a.m., the pain response on the MAR was left blank. The Peri-OpD acknowledged Patient N202's pain reassessments were not documented and should have been.

During a concurrent interview and record review on 11/3/21, at 2:45 p.m., with the Peri-OpD, Patient N203's MAR dated 10/8/21 was reviewed. The MAR indicated on 10/8/21 at 8:39 a.m., Patient N203 pain was assessed to be a three out of 10. Patient N203 was given Ketorolac 30 mg IV at 8:39 a.m. At 9:39 p.m., an hour later, the pain response on the MAR was left blank. The Peri-OpD acknowledged Patient N203's pain reassessment was not documented and should have been.

During a concurrent interview and record review on 11/3/21, at 3:00 p.m., with the Peri-OpD, Patient N204's MAR dated 10/2/21 was reviewed. The MAR indicated on 10/2/21 at 5:16 a.m., Patient N204 pain was assessed to be a four out of 10. Patient N204 was given Hydromorphone (a narcotic medication to treat moderate to severe pain) 0.5 mg IV at 5:28 a.m. At 6:28 a.m., an hour later, the pain response on the MAR was left blank. Patient N204's MAR dated 10/3/21 was reviewed. The MAR indicated on 10/3/21 at 5:34 a.m., Patient N204 pain was assessed to be a five out of 10. Patient N204 was given Ibuprofen 600 mg tablet at 5:34 a.m. At 6:34 a.m., the pain response on the MAR was left blank. The Peri-OpD acknowledged Patient N204's pain reassessments were not documented and should have been.

During a concurrent interview and record review on 11/3/21, at 3:50 p.m., with the Peri-OpD, Patient N205's MAR dated 10/10/21 was reviewed. The MAR indicated on 10/10/21 at 9:36 p.m., Patient N205 pain was assessed to be a five out of 10. Patient N205 was given Ibuprofen 600 mg tablet at 9:36 p.m. At 10:36 p.m., an hour later, the pain response on the MAR was left blank. Patient N205's MAR dated 10/11/21 was reviewed. The MAR indicated on 10/11/21 at 4:00 a.m., Patient N205 pain was assessed to be a five out of 10. Patient N205 was given Ibuprofen 600 mg tablet at 4:00 a.m. At 5:00 a.m., the pain response on the MAR was left blank. The Peri-OpD acknowledged Patient N205's pain reassessments were not documented and should have been.

During a review of the facility's policy and procedure titled, "Pain Management", dated 2/18, indicated in part ... "B: Reassessment ...1. Pain reassessment will occur once per shift, after pain management interventions, and according to the individual needs of the patient ...2. Reassessment will include at least the following: a. intensity/level of pain (pain scale number) ...b. location ...c. sedation level when opioids are in use ... 3. Document the reassessment ...C: Pain scale-assess/reassess the patient's pain intensity and goal for relief using one of the scales below: numeric scale (0-10) ...no pain=0, mild pain= 1-3, moderate pain=4-6, severe pain= 7-10."





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5. During a concurrent interview and record review on 11/3/21 at 2:45 p.m., with licensed nurse (LN 10), Patient N501 was given one tablet of oxycodone (a pain medication) on 11/3/21 at 6:48 a.m., for lower back pain and another tablet of oxycodone at 11:23 a.m., for lower back pain. No documentation of pain assessment pre and post medicatiopn was located in the patient's medical record . LN 10 acknowledged pain reassessments for Patient N501 were not documented and should have been.
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During a concurrent interview and record review on 11/3/21 at 3:50 p.m., with LN 10, Patient N503 was given morphine 2mg IV push (IVP) on 7/22/21 at 5:57 p.m., for abdominal pain. No pain reassessment was documented in the patient's medical record was located . LN 10 acknowledged the pain reassessment was not documented for Patient N503 and should have been.

Review of the facility policy titled, "PAIN MANAGEMENT", revised 2/21/18, indicated in part ... "Pain reassessment will occur once per shift, after pain management interventions, and according to the individual needs of the patient. Document the reassessment."

Based on interview and record review, the facility failed to ensure the patients and witness verifying the patient signature on the consent forms printed their names legibly for two of 33 sampled patients (Patient N303 and Patient N401),

These failures resulted in unidentifiable signatures documented on the consent forms with the potential to result in patients choices not being carried out or protected.

Findings:

During a concurrent interview and record review, on 11/3/21, at 2:43 p.m., with the director of patient access (DPA), Patient N401's "Conditions of Registration (California Only)" (COR), dated 10/28/21, at 2:54 p.m., was reviewed. The "COR" indicated, an illegible witness signature and no printed witness name to identify the signature ownership. DPA stated, "Not the correct process," for witnessing a consent, the witness's name should be printed and readable and it was not.



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2. The facility policy and procedure titled "Consent and Informed Consent-California", dated 6/2/21, in J (2) part indicated "a. The witness should legibly print his or her name, sign the document and note the date and time the witness signed the document."

During a review of Patient 303's central line placement consent form with administrator (Admin 1) and Admin 2 on 11/2/21 at 11:10 a.m., the consent form on the "Print Name" signature and witness areas were blank. Admin 1 and Admin 2 were asked who had signed and witness the consent form and both acknowledged not knowing who had signed and witnessed the consent form . Admin 1 and Admin 2 further acknowledged and confirmed the "Print Name" areas must be completed to know who's names those signatures belong to and it was not so.

Based on observation and interview, the facility failed to remove expired laboratory (lab) supplies from patient care areas.

This failure had the potential to result in unnecessary repeated lab blood sample collection and unstable intravenous (IV- in the vein) fluid use in patients.

Findings:

During a review of the facility's policy and procedure (P&P) titled, "Supply Distribution, Par Carts, Order Guides," dated 2/13/19, the "P&P" indicated, "Restocking is done on the FIFO system (First In, First Out) ... will be checked for outdated items at least once a month. The department supervisor will schedule a week each month for each nursing unit supply room to be checked for outdated items. Items that expire the following month will be pulled at that time as well."

During a concurrent observation and interview on 11/1/21, at 11:20 a.m., with a director of laboratory (DOL), in the emergency department (ED) lab station, two expired bottles of Myco/F Lytic Culture Vials (blood collection containers) were observed on the lab supply cart. DOL verified the expired dates (2021/06/30 and 2020/10/31). DOL acknowledged they were expired and should not be there.

During a concurrent observation and interview on 11/2/21, at 10:57 a.m., with an ED manager (NM4), in the ED trauma room, Critical Care Cart #EZ10 was observed to have three bags of expired 5% Dextrose IV fluid in 100ml (milliliter) bags. NM4 verified the expired dates (JUL 21) and stated they were expired and should not be there.

Based on observation, interview, and record review, the facility failed to ensure one of 33 sampled patients (Patient N601), had secured protected health information (PHI).

This failure had the potential to result in Patient N601's private health information being viewed by an unauthorized staff, patient, or visitor.


Findings:


During a review of the facility's policy and procedure (P&P) titled, "Confidentiality of Protected Health Information," dated 8/31/15, the "P&P" indicated, "Breaching patient confidentiality can occur in a variety of ways ... "Carelessness" is defined as a breach that occurs when patient information is unintentionally or carelessly accessed or reviewed by oneself, and/or revealed to others without a legitimate need to know the patient information. Examples include, but are not limited to ... Leaving a computer work station unsecured (especially with PHI displayed onscreen)."

During a concurrent observation and interview on 11/1/21, starting at 10:19 a.m., with an emergency department manager (NM4), in the Fasttrack Waiting Results Room, a physician assistant (PA2) was observed to leave the computer workstation with the computer screen still displaying Patient N601's health information. Upon return to the unattended computer, PA2 stated they went to, "The front intake room." PA2 further stated, "What this really needs is a privacy screen." PA2 also stated they were not aware of the need to secure the computer when walking away from it.

During a review of PA2's "Annual Provider, Contractor, Vendor Representative, & Volunteer Compliance Education - 2021" (CEd), dated 5/4/21, the "CEd" indicated PA2 attested, on page 15, to receiving "Health Information Management" training.

The governing board failed to ensure that the hospital had active hospital-wide programs for the surveillance, prevention, and control of HAIs and other infectious diseases. The programs must demonstrate adherence to nationally recognized infection prevention and control guidelines, as well as to best practices for improving and reducing the development and transmission of HAIs and antibiotic resistant organisms. Infection prevention and control problems issues identified in the programs must be addressed in collaboration with the hospital-wide quality assessment and performance improvement (QAPI) program. Refer to A0749 and A0750.

The CONDITION OF PARTICIPATION is not met as evidenced by:

1. Lacked infection control IC surveillance at the hospital lobby entrance for visitors, Central Line policy implementation and adherence to center for disease control CDC guidelines regarding N-95 respirator use.
2. Cleaning of the operating rooms (OR's) between patients (room turn over) was not done according to policy and procedure and The Association of Peri-Operative Registered Nurses (AORN) guidelines in labor and delivery and surgical services.
3. Hand hygiene was not performed per policy and procedure during room turnover in surgical services and delivery of patient care.
4. Contact time (time product should stay wet) of disinfectant/cleaner was not adhered to while mopping the operating room (OR) floors between patients (room turn over) according to manufacturer's instructions for use (MFU's).
5. IV (Intravenous) tubing ports were not cleaned prior to medication administration in the operating room (OR).
6. Personal protective equipment (PPE) was not worn during cleaning of a GI endoscope (a long, thin tube with a tiny camera attached at the end used to see inside the intestines).
7. Glucometer (device used to measure blood sugar) was not cleaned/disinfected per policy and procedure in the Pre-op/PACU (Preoperative/Post-anesthesia care unit).
8. Gloves and cleaning/disinfectant wipes used to clean dirty equipment in the operating room (OR) were removed by staff and placed in their scrub jacket pocket.
9. A glove that was dropped on the dirty floor of the labor and delivery operating room (OR) was put back into a clean box of gloves on the supply cart then the gloves in the box continued to be used by staff to clean the OR.
10. Staff did not change gloves after cleaning dirty equipment in the labor and delivery operating room (OR) before getting supplies from the clean supply cart.
11. Staff did not date and label opened milk cartons.
12. Patient food brought in from outside sources was stored inside the patient refrigerator nourishment supply.
13. Ice machine located in 1North not maintained in sanitary condition.
14. Facility was using extended use of N-95 respirators (face mask filtering 95% of particulates, virus, bacterial...).
15. Facility staff was doffing (removing) personal protective equipment (PPE) outside the isolation rooms.
16. Staff did not replace the HME filters in the ventilators in-line circuit as per manufacturer's IFUs.
17. NICU bassinets, light and IV pump were not covered to indicate whether items were clean or not clean as per their policy and procedure.
18. N-95 respirators were being wipe down with a Sani-cloth by staff between each use.

The cumulative effect of these systemic problems resulted in the governing board's inability to ensure the provision of quality patient care in a safe environment.

Based on observation, interview and record review the hospital failed to ensure the IC (infection control) Officer had a system for implementation of the IC plan and policies governing for preventing and controlling the transmission of infections between the hospital and other settings, and implementing policies and procedures for preventing pathogen transmission in healthcare settings when the hospital:

a) Lacked IC surveillance at the hospital lobby entrance for visitors.
b) Lack of Central Line policy implementation.
c) Lack of adherence to center for disease control CDC guidelines regarding N-95 respirator use.

These failures had the potential for a hospital widespread infection incidents.


Findings:

a). Review of California Department of Public Health, all facilities letter 21-31, dated 8/12/21, indicated in part..."CDPH is requiring GACHs to develop and implement processes for verifying the vaccination status of acute care visitors, and for tracking documentation of SARS-COVID-2 diagnostic tests results of acute care visitors..."

During a observation on 11/3/21, starting at 3:15 p.m., at the hospital front entrance lobby, contracted parking attendant (PA1), was observed at front desk checking visitors to the hospital at entrance of hospital . PA1 was observed waiving one visitor into the lobby without stopping at desk for surveillance.
During a interview on 11/3/21, starting at 3:16 p.m., PA1 was asked if the visitor had been checked for vaccination status, PA1 stated, "I don't check the status every time."
During a interview on 11/3/21, starting at 3:20 p.m., with infection control staff (IC2), when asked if the hospital infection control plan and policy has the infection control office oversight for visitors, IC2 stated, "No, we don't we do in the in-patient and out-patient but not the lobby." Hospital unable to produce policy or procedure for visitor surveillance or limitation.


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b) The facility's policy and procedure titled "Intravenous Lines-Central and Peripheral", dated 12/11/20, in the Central Line Insertion Procedure indicated "1. After the line is placed, the necessity for the line must be reviewed and documented on a daily basis by the physician."

During a tour of the intensive care unit (ICU) on 11/1/21 at 10:35 a.m., Patient 303 was observed with a central line (intravenous IV line that is inserted into a large vein (superior vena cava) typically in the neck or near the heart for therapeutic or diagnostic purposes (as to administer medicines or fluids or withdraw blood) on the left side of chest.

A review of Patient 303's clinical record was conducted with two Administrators (Admin 1) and (Admin 2) on 11/1/21 at 11:10 a.m., Central line was inserted on 10/21/21 for medication delivery and venous access. On 10/23/21, 10/24/21, 10/29/21, 10/30/21 and 10/31/21 there was no necessity for central line documented by the physician for these dates. Admin 1 and Admin 2 acknowledged and confirmed that five out of ten dates that the patient had the central line in place there was no review and documentation by the physician for the necessity of the central line.

During an interview with the infection preventionist (IP 1) on 11/2/21 at 3:25 p.m., the IP agreed that the physician needs to document daily the reason or necessity for the central line to be in place. The central line left in place without necessity can cause an infection, therefore, it must be removed as soon as possible to decrease the patient's risk for infection.

c) According to the centers for disease control (CDC), updated 9/21, considerations are intended for use by federal, state, and local public health officials, respiratory protection program managers, leaders in ...infection prevention and control programs, and other leaders in healthcare settings who are responsible for developing and implementing policies and procedures for preventing pathogen transmission in healthcare settings. CDC indicated "N95 respirators (face mask filtering 95% of particles, virus...) are the personal protective equipment (PPE) most often used to control exposures to infectious pathogens transmitted via the airborne route, though their effectiveness is highly dependent upon proper fit and use. N95 respirators are intended to be used once and then properly disposed of and replaced with a new N95 respirator."

During an interview with licensed nurse LN 4 on 11/1/21 at 10:46 a.m., who was caring for Patient 300 that had been diagnosed with COVID -19 virus positive (contagious airborne disease) and was in Airborne isolation precautions. LN 4 explained that part of the PPE donning off (removing) included to remove the N-95 respirator, wipe it down with a Sani-cloth wipe, then, store the N-95 respirator inside a plastic bag until the next time the PPE was use. LN 4 was asked again did you said you remove the N-95 respirator, wipe it down with a Sani-cloth wipe then store the N-95 inside a plastic bag .... LN 4 stated "Yes, I did".

During an interview with the infection preventionist (IP 1) on 11/2/21 at 11:25 a.m., it was communicated that staff was wiping down the N-95 respirators with a Sani-cloth before storing the N-95. IP 1 stated "Ohh, wiping down the N-95 respirators with Sani-wipes is not okay. I will educate staff..."

Based on observation, interview, and record review the hospital failed to maintain infection control practices and processes when:

1. Cleaning of the operating rooms (OR's) between patients (room turn over) was not done according to policy and procedure and The Association of Peri-Operative Registered Nurses (AORN) guidelines in labor and delivery and surgical services.

2. Hand hygiene was not performed per policy and procedure during room turnover in surgical services.

3. Contact time (time product should stay wet) of disinfectant/cleaner was not adhered to while mopping the operating room (OR) floors between patients (room turn over) according to manufacturer's instructions for use (MFU's).

4. IV (Intravenous) tubing ports were not cleaned prior to medication administration in the operating room (OR).

5. Personal protective equipment (PPE) was not worn during cleaning of a GI endoscope (a long, thin tube with a tiny camera attached at the end used to see inside the intestines).

6. Glucometer (device used to measure blood sugar) was not cleaned/disinfected per policy and procedure in the Pre-op/PACU (Preoperative/Post-Anesthesia care unit).

7. Gloves and cleaning/disinfectant wipes used to clean dirty equipment in the operating room (OR) were removed by staff and placed in their scrub jacket pocket.

8. A glove that was dropped on the dirty floor of the labor and delivery operating room (OR) was put back into a clean box of gloves on the supply cart then the gloves in the box continued to be used by staff to clean the OR.

9. Staff did not change gloves after cleaning dirty equipment in the labor and delivery operating room (OR) before getting supplies from the clean supply cart.

10. Staff did not date and label opened milk cartons.

11. Patient food brought in from outside sources was stored inside the patient refrigerator nourishment supply.

12. Ice machine located in 1North not maintained in sanitary condition.

13. Staff disposed soiled linen and gown outside the isolation room.

14. Staff did not perform hand hygiene according to policy and procedure.

15. Facility staff were extending the use of N-95 respirators (face mask filtering 95% of particulates, virus, bacterial...).

16. Facility staff was doffing (removing) personal protective equipment (PPE) outside the isolation rooms.

17. Staff did not replace the HME filters in the ventilators in-line circuit as per manufacturer's IFUs.

18. NICU bassinets were not covered to indicate whether bassinet was clean or not clean as per their policy and
procedure.

19. Light and IV pump attached to NICU bassinets were not covered to indicate whether items were clean or not
clean as per their policy and procedure.

20. N-95 respirators were being wiped down with a Sani-cloth by staff between each use.

These facility failures had the potential to result in cross-contamination (the transfer of harmful bacteria) that could impact patients' health and safety and cause preventable HAIs (Healthcare Associated Infections).

Findings:

1. During an observation and concurrent interview, at 9:50 a.m., on 11/3/21, in OR 1 (operating room), licensed nurse (LN 8) cleaned the OR table while environmental services (EVS 1) cleaned the periphery of the room. LN 8 finished cleaning the OR table and assisted EVS 1 in cleaning the periphery of the room. EVS 1 then asked LN 8 if OR table was clean, and LN 8 replied yes. The cleaning method flow pattern went from clean to dirty back to clean. Surgical director (SD) acknowledged LN 8 and EVS 1 were not following proper cleaning sequence.

According to AORN guidelines for perioperative practice titled: "Environmental Cleaning" dated 2012 - 2021, indicated in part ... "All personnel should take a precautionary measure to limit transmission of microorganisms when performing environmental cleaning and handling waste materials ... perform cleaning activities in a methodical pattern that limits transmission of microorganisms ... cleaning should be progress from clean to dirty areas ... the center of the room, where most of the patient care occurs, is most likely to have higher levels of contamination."


2. During an observation and concurrent interview on 11/3/21, at 10:20 am, in OR 1 (operating room) during room turn over (cleaning between patients), environmental services (EVS 1) changed gloves multiple times without performing hand hygiene. Confirmed with surgical director (SD) that EVS 1 should be performing hand hygiene between glove changes.

During a review of the facility policy titled, "ENVIRONMENTAL CLEANING IN THE PERIOPERATIVE SETTING", revised 6/20/2019, indicated in part ... "Remove gloves and clean hands."
According to AORN guidelines for perioperative practice titled: "Environmental Cleaning" dated 20112 - 2021, indicated in part ... "All personnel should take a precautionary measure to limit transmission of microorganisms when performing environmental cleaning and handling waste materials ... healthcare personnel handling contaminated items or cleaning contaminated surfaces must wear personal protective equipment (PPE) to reduce the risk of exposure to blood, bodily fluids, and other potentially infectious materials ... hand hygiene should be performed when PPE is removed and as soon as possible after hands are soiled."

3. During an observation and concurrent interview on 11/4/21, at 10:16 a.m., in the L&D (labor and delivery) OR (operating room), environmental services (EVS 2) mopped the floor and immediately walked on the floor and did not wait for the contact time (time product should remain wet). Confirmed with Peri-OpD (perioperative director) EVS 2 is not following contact time and should not be mopping floor and immediately walking on it.

During a review of the MFU's for the disinfectant cleaner used to mop the floor titled, "Defender", undated, indicated in part ... "Defender is a Healthcare disinfectant ... with a 4-minute contact time."

4. During an observation and concurrent interview on 11/1/21, at 4:10 pm, in OR 4 (operating room), anesthesiologist (AN) administered medication through the IV ports without cleaning the ports multiple times. Confirmed with surgical manager (SM) AN should be cleaning IV ports prior to administering any medications through the port.

During a review of the facility policy titled, "ISOLATION: STANDARD AND TRANSMISSION - BASED PRECAUTIONS", revised 3/7/2016, indicated in part ... "Aseptic technique is used to avoid contamination of sterile injection equipment. Alcohol is used to disinfect all containers (i.e., vials, ampoules, ports) of parenteral medications prior to entry."


5. During an observation and concurrent interview on 11/1/21, at 10:35 a.m., GI Tech (GT) was cleaning the GI endoscope without a face shield, GT stated I have a face shield that I normally wear but I forgot. Confirmed with surgical manager (SM) and accreditation (AN), GT should be wearing PPE including a face shield.

During a review of the facility policy titled, "GI ENDOSCOPE CLEANING AND DISINFECTION", revised 5/15/19, indicated in part ... "Cleaning Guidelines: Wear gloves, face shields, masks, water impervious gowns."

According to AORN guidelines for perioperative practice titled: "Environmental Cleaning" dated 20112 - 2021, indicated in part ... "All personnel should take a precautionary measure to limit transmission of microorganisms when performing environmental cleaning and handling waste materials ... healthcare personnel handling contaminated items or cleaning contaminated surfaces must wear personal protective equipment (PPE) to reduce the risk of exposure to blood, bodily fluids, and other potentially infectious materials ... hand hygiene should be performed when PPE is removed and as soon as possible after hands are soiled."

6. During an observation and concurrent interview on 11/2/21, at 12:00 p.m., in the post-op, licensed nurse (LN 7) was cleaning a glucometer. When LN 7 was asked what she does with the glucometer between patients, LN 7 stated "I wipe it down with a grey wipe and let it air dry. It takes 3 minutes to dry and then I put it back into the docking station."

During an observation and concurrent interview on 11/3/21, at 11:02 a.m., in the post-op, LN 9 was asked to demonstrate and verbalize what is done with the glucometer between patients. LN 9 got one bleach wipe, wiped down the glucometer and placed it on a paper towel. LN 9 verbalized getting one wipe, wiping down glucometer, place it on a paper towel until it dries, and then place it on the docking station. Confirmed with Accreditation (AC), surgical director (SD), and surgical manager (SM) this is not following the facility policy and procedure for cleaning/disinfecting the glucometer.

During a review of the facility policy titled, "GLUCOSE TESTING BY NOVA STATSTRIP", revised 11/2/20, indicated in part ... "Cleaning the bedside unit: Clean and disinfect the external surfaces of the meter after each patient contact with a fresh Chlorox Germicidal Wipe ... or equivalent. Remove a fresh germicidal wipe from the canister and wipe the external surface of the meter thoroughly. Discard the soiled wipe. Disinfecting the Meter: Using a new, fresh germicidal wipe, thoroughly wipe the surface of the meter (top, bottom, left and right sides) a minimum of 3 times horizontally and 3 times vertically avoiding the meter's barcode scanner and electrical connector. Ensure the meter surface stays wet for 1 minute and then is allowed to air dry for an additional 1 minute."

7. During an observation and concurrent interview on 11/3/21, at 10:50 a.m., in OR 1 (operating room) during room turn over (cleaning between patients), environmental services (EVS 1) cleaned dirty equipment with wipes, removed gloves, and placed dirty wipes and gloves in their scrub jacket pocket. Confirmed with surgical director (SD) that EVS 1 should be disposing dirty items.

During a review of the facility policy titled, "ENVIRONMENTAL CLEANING IN THE PERIOPERATIVE SETTING", revised 6/20/19, indicated in part ... "Personal protective equipment (PPE) must be worn according to the Occupational Safety and Health Administration (OSHA) Bloodborne Pathogen Standard when disposing of waste that could results in exposure to bloodborne or other potentially infectious microorganisms and hazardous material."

Review of the OSHA website, osha.gov/laws-reg/regulations/standardnumber/1910/1910.1030, accessed on 11/12/21, indicated "When personal protective equipment is removed it shall be placed in an appropriately designated area or container for storage, washing, decontamination or disposal."


8. During an observation and concurrent interview on 11/4/21, at 8:40 a.m., in labor and delivery OR (operating room) during room turn over (cleaning between patients), environmental services (EVS 2) dropped a glove on the dirty OR floor, picked up the glove, and put the dirty glove back into the box of clean gloves on the supply cart. EVS 2 continued to use gloves from the glove box with the dirty glove to clean the OR. Confirmed with licensed nurse (LN 12) that EVS 2 should have disposed of dirty glove and not placed it back into the clean box of gloves, that the whole box of gloves are contaminated and EVS 2 should not be using them to clean.

Review of the OSHA website, osha.gov/laws-reg/regulations/standardnumber/1910/1910.1030, accessed on 11/12/21, indicated "When personal protective equipment is removed it shall be placed in an appropriately designated area or container for storage, washing, decontamination or disposal. Disposable (single use) gloves such as surgical or examination gloves, shall be replaced as soon as practical when contaminated."

According to AORN guidelines for perioperative practice titled: "Environmental Cleaning" dated 20112 - 2021, indicated in part ... "All personnel should take a precautionary measure to limit transmission of microorganisms when performing environmental cleaning and handling waste materials ... always consider floors in the perioperative practice setting to be contaminated ... healthcare personnel handling contaminated items or cleaning contaminated surfaces must wear personal protective equipment (PPE) to reduce the risk of exposure to blood, bodily fluids, and other potentially infectious materials ... hand hygiene should be performed when PPE is removed and as soon as possible after hands are soiled."

9. During an observation and concurrent interview on 11/4/21, at 9:25 a.m., in labor and delivery OR (operating room) during room turn over (cleaning between patients), environmental services (EVS 2) removed clean supplies from the supply cart with dirty gloves on. Confirmed with licensed nurse (LN 12) that EVS 2 should not be touching clean supplies with dirty gloves.

During a review of the facility policy titled, "ENVIRONMENTAL CLEANING IN THE PERIOPERATIVE SETTING", revised 6/20/2019, indicated in part ... "Personal protective equipment (PPE) must be worn according to the Occupational Safety and Health Administration (OSHA) Bloodborne Pathogen Standard when disposing of waste that could results in exposure to bloodborne or other potentially infectious microorganisms and hazardous material."

Review of the OSHA website, osha.gov/laws-reg/regulations/standardnumber/1910/1910.1030, accessed on 11/12/21, indicated "When personal protective equipment is removed it shall be placed in an appropriately designated area or container for storage, washing, decontamination or disposal. Disposable (single use) gloves such as surgical or examination gloves, shall be replaced as soon as practical when contaminated."

According to AORN guidelines for perioperative practice titled: "Environmental Cleaning" dated 20112 - 2021, indicated in part ... "All personnel should take a precautionary measure to limit transmission of microorganisms when performing environmental cleaning and handling waste materials ... always consider floors in the perioperative practice setting to be contaminated ... healthcare personnel handling contaminated items or cleaning contaminated surfaces must wear personal protective equipment (PPE) to reduce the risk of exposure to blood, bodily fluids, and other potentially infectious materials ... hand hygiene should be performed when PPE is removed and as soon as possible after hands are soiled."










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10. During a tour of the 1North nourishment room on 11/1/21 at 11:13 a.m., there were two small, single use milk cartons inside the reach in refrigerator that were opened, undated, and unlabeled.

Concurrent interview with 1North Manager (1NM) confirmed the two small, single use milk cartons were open undated and unlabeled and concurred it should be consumed and discarded after it is opened.

11. During an observation on 11/1/21 at 11:13 a.m., a bag of food brought from home labeled belonging to room 118, dated 10/29/21 was stored inside the patient refrigerator nourishment supply.

Concurrent interview with 1North Manager (1NM) explained the patient refrigerator is only for hospitals nourishment supply and the food labeled room 118 should not have been stored inside the refrigerator.

Concurrent review of the "Patient Food Policies Summary" dated 2021 indicated, " ...Patient food brought in from outside sources is not to be stored in the patient refrigerator ..."

12. During a tour of the 1 North nutrition room on 11/1/21 at 11:20 a.m., the ice machine had a black substance around the water and ice dispenser exit. Concurrent interview with the 1 North Manager (1NM) and Program Specialist Informatics (PSI) both confirmed the water and ice dispenser exit were not clean.

During an interview on 11/1/21 at 11:22 a.m., Maintenance Technician (MT1) confirmed the ice machine located inside the nutrition room has a black substance in its dispenser exit and he indicated another technician is responsible for its maintenance.

During an interview on 11/1/21 at 11:58 a.m., Maintenance Technician (MT2) explained the pre-filter is changed every month, the main filter is changed every six months and the general checking of the machine is done quarterly. MT2 also stated, a technician (MT3) who is off today oversees its maintenance. Concurrent observation of the internal compartment of the ice machine revealed a dark substance around the metal or steel is in direct contact with the ice. MT1 also explained, the metal keeps the ice into pieces. MT1, MT2, 1NM and PSI acknowledged and confirmed the ice machine was not clean. MT1 and MT2 confirmed the maintenance log did not indicate specifically whether the metal that touches the ice was cleaned or not.

Facility procedure review on 11/3/21 titled "Icemaker Cleaning Procedure", undated, revealed the recommended semi-annual cleaning of the icemaking system can be cleaned in place without disassembling water system.

13. During an observation on 11/1/21 at 11:48 a.m., a certified nurse assistant (CNA) was observed exiting COVID isolation room 100 and entering the Ante room wearing her soiled gown. CNA then removed her soiled gown and disposed her gown and soiled linen into the hamper. CNA confirmed she did not remove her soiled PPE before exiting the COVID isolation room and she explained, staff removes soiled gown and linen and dispose it in the hamper outside of the isolation room.

Review of hospital procedure titled "How to Safely Remove Personal Protective Equipment (PPE)" undated indicated, " ...Remove all PPE before exiting the patient room except a respirator ..."

14. During an observation on 11/2/21 at 12:49 p.m., a telemetry unit registered nurse (LN12) was observed exiting room 257 then removed her washable gown and disposed it into the hamper located outside the isolation (COVID) room. LN12 did not sanitize her hands and opened the yellow PPE supply cart, donned a pair of gloves, and wiped the top cover of the soiled linen hamper with Sani- cloth and proceeded to the nursing station without removing her gloves and without sanitizing her hands. Concurrent interview with LN12 confirmed she did not sanitize her hands and should have sanitized her hands after removing personal protective equipment (PPE).

Review of hospital procedure titled "How to Safely Remove Personal Protective Equipment (PPE)" undated indicated in part, "4. Wash hands or use an alcohol-based hand sanitizer immediately after removing all PPE."






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15. According to the center for disease control (CDC), Strategies for Optimizing the Supply of N95 Respirators, Updated Sept. 16, 2021, indicates "Situational update as of May 2021: The supply and availability of NIOSH-approved respirators have increased significantly over the last several months. Healthcare facilities should not be using crisis capacity strategies at this time and should promptly resume conventional practices. N95 respirators (face mask filtering 95% of particulates, virus ...) are intended to be used once and then properly disposed of and replaced with a new N95 respirator."

During an interview with license nurse LN 4 on 11/1/21 at 10:46 a.m., LN 4 explained s/he uses the N-95 respirator five times with the same Covid-19 virus (very contagious airborne disease) positive patient in airborne isolation precautions before obtaining a new N-95 respirator. LN 4 has been instructed to use the N-95 respirator five times before discarding it.

During an interview with license nurse LN 5 on 11/2/21 at 10:50 a.m., caring for a Covid -19 virus positive patient who was on airborne isolation precautions explained that management instructed for staff to use the N-95 respirator five times before obtaining a new N-95 respirator.

During an interview with the infection preventionist (IP 1) on 11/2/21 at 11:25 p.m., IP explained staff should be using an N-95 respirator five times per shift or before obtaining a new one. IP confirmed the facility is using extended use of N-95 respirators. IP 1 stated "We have the extended (PPE) use protocols provided by infection control corporate."

16. The facility's MODEL PLAN: COVID-19 EMEGENCY TEMPORARY STANDARD PLAN FOR HEALTHCARE, undated, in the PLAN: COMPLIANCE C, 4., part indicated "Standard and Transmission- based precautions are defined by policy and utilized by employees when indicated in accordance with center for disease control (CDC) guidelines."

a. The facility's PPE donning and doffing pictogram (contain CDC logo) which was attached to the isolation room door, undated, indicated " ...Remove all PPE before exiting he patient room ..."

During an interview with license nurse LN 4 caring for a patient diagnosed with Covid-19 virus (very contagious airborne disease) on 11/1/21 at 10:46 a.m., LN 4 explained the PPE doffing (removing) procedure as followed "I would take off gloves and place into trash can inside the room, sanitized my hands, and exit the room into hallway. I would take off gown and place inside linen hamper (located outside of room). Remove face shield and wipe it down with Sani-wipe. Take off surgical mask throw inside trash can (located outside of room). Remove N-95 mask and wipe it down with a Sani-wipe. Place N-95 and face shield inside plastic bag for next use ..." LN 4 acknowledged and confirmed performing the personal protective equipment (PPE) doffing procedure outside the patient's room in the hallway.

During an interview with license nurse LN 5 on 11/2/21 at 10:50 a.m., caring for a Covid -19 virus positive patient who was on airborne isolation precautions explained that the PPE removal procedure was performed outside the patient's room in the hallway. The only item that was removed and discarded into the inside trash can was the gloves, however, everything else was discarded in the linen hamper and trash can outside the room.

During an interview with the infection preventionists (IP 1) on 11/2/21 at 3:35 p.m., IP acknowledged and confirmed that staff had been performing the PPE removal outside the patient's isolation room. IP 1 explained since not all the isolation rooms in the ICU have an ante- room area to remove the PPE that's the reason the staff was instructed to remove the PPE outside of the room in the hallway. This is also the reason the washable gown linen hamper and the trash can are outside of the room.

During another interview with the infection preventionists (IP 1) on 11/4/21 at 10:00 a.m., IP re-confirmed the facility practice for staff to remove the PPE outside the isolation rooms. Furthermore, IP acknowledged there is no regulatory body e.g. CDC, that supports such practice.

17. During a tour of the intensive care unit (ICU) and concurrent interview with Administrator (Admin 1) on 11/1/21 at 10:25 a.m., patient 303 was observed intubated with an in-line circuit heat and moisture exchanger (HME) filter (microbiological filter) with no date on the filter or on the in-line blue circuit. Admin 1 explained the HME filters are changed as needed or if condensation is observed.

A review of Patient 303's clinical record was conducted with Admin 1 present navigating the electronic record on 11/2/21 at 11:30 a.m., Patient 303 was intubated on 10/30/21 at 7:12 p.m. The ventilator's in-line circuit HME filter was changed on 11/2/21 at 5:30 a.m. Admin 1 acknowledged and confirmed the HME filter was only changed on 11/2/21.

During a review of the ventilator circuit HME filter manufacturer's instructions for use (IFUs) provided by facility and concurrent interview with Admin 1 on 11/3/21 at 2:35 p.m., Admin 1 acknowledged that the HME filter was not changed every 24 hours. Admin stated "Yes, I agree the HME filter was not changed every 24 hours as per the manufacturer's IFUs."

The facility's policy and procedure titled "Disposable Circuits-Frequency for Replacing" dated 9/28/21, indicated "Disposable circuits will be replaced at the following frequency: or if visibly soiled or mechanically malfunctioning ... 2. HME's: as needed."

18. During a tour of the neonatal intensive care unit (NICU) accompany by the peri-operative director (Peri-OpD) on 11/1/21 at 11:11 a.m., a bassinet was observed without any indication (no linen cover over) whether bassinet was clean or dirty. The Peri-OpD explained bassinets are clean and a linen cover is placed over to indicate the bassinet is clean ready to be use. The Peri-OpD acknowledged and confirmed the bassinet had no linen cover over to indicate the bassinet was clean. Peri-OpD stated "I know this one (bassinet) does not have a cover. I will have environmental services (EVS) clean it."

The facility's policy and procedure titled "Bassinet, Warmer, Crib Cleaning, dated 6/29/20, indicated "Bassinets, warmers, cribs, (child/neonate/infant equipment) will be cleaned and sanitized port discharge of patient ... H. Place a liner cover over clean Warmer, Crib, and Bassinet."

19. During the same NICU tour accompany by the Peri-OpD on 11/1/21 at 11:15 a.m., a bassinet was observed with a fluorescent light and an intravenous infusion (IV) pump attached to the bassinet. The bassinet was covered however the light and the pump were not covered with anything. The Peri-OpD was asked the process for distinguishing whether the light and IV pump were clean or dirty. The Peri-OpD explained that EVS cleans and disinfects the bassinet, and everything attached to it (light and IV pump) and covers the light and IV pump with a plastic liner. The Peri-OpD acknowledged the light, and the IV pump were not covered with the plastic liner therefore they were considered not clean. The Peri-OpD stated "The light and (IV) pump are not covered. I will have EVS clean everything (bassinet, light and pump) again and cover everything."

The facility's policy and procedure titled "Equipment Cleaning and Monitoring of Non-Critical Devices," dated 10/21/20, was reviewed and clarified with Administrator (Admin 1) on 11/3/21. The policy indicated "It is the policy of {Facility's Name} to maintain hospital equipment in a clean, safe and sanitary manner and to maintain infection control standards through proper cleaning and disinfection. E. d. indicated "A clear bag will be placed over the cart to show that it has been cleaned and is ready to use." Admin 1 clarified that this is the process for any non-critical devices (cart, IV pump, light ...).

20. According to the centers for disease control (CDC), updated 9/21, considerations are intended for use by federal, state, and local public health officials, respiratory protection program managers, leaders in ...infection prevention and control programs, and other leaders in healthcare settings who are responsible for developing and implementing policies and procedures for preventing pathogen transmission in healthcare settings. CDC indicated "N95 respirators are the personal protective equipment (PPE) most often used to control exposures to infectious pathogens transmitted via the airborne route, though their effectiveness is highly dependent upon proper fit and use. N95 respirators are intended to be used once and then properly disposed of and replaced with a new N95 respirator."

During an interview with licensed nurse LN 4 on 11/1/21 at 10:46 a.m., who was caring for Patient 300 that had been diagnosed with COVID -19 virus positive and was in Airborne isolation precautions. LN 4 explained that part of the PPE donning off (removing) included to remove the N-95 respirator, wipe it down with a Sani-cloth wipe, then, store the N-95 respirator inside a plastic bag until the next time the PPE was use. LN 4 was asked again did you said you remove the N-95 respirator, wipe it down with a Sani-cloth wipe then store the N-95 inside a plastic bag .... LN 4 stated "Yes, I did".

During an interview with the infection preventionist (IP 1) on 11/2/21 at 11:25 a.m., it was communicated that staff was wiping down the N-95 respirators with a Sani-cloth before storing the N-95. IP 1 stated "Ohh, wiping down the N-95 respirators with Sani-wipes is not okay. I will educate staff."


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16. b. During a concurrent observation and interview on 11/2/21, at 3:55 p.m., with a telemetry manager (NM3), outside patient room 257, a licensed nurse (LN12) and certified nursing assistant (CNA1) were observed to exit an isolation room and doff (remove the contaminated gown) in the hallway. NM3 verified the observation and stated, "Removed outside the room." NM3 further stated the contaminated gown is placed in the soiled linen cart outside of the room in the hallway.

Based on interview, clinical and document review, the hospital failed to provide surgical services in accordance with the hospital policy and procedures and nationally recognized guidelines.(Refer to A-0951 and A-0955)

The CONDITION OF PARTICIPATION was not met when:

1. A miscellaneous surgical item was left for one (Patient N400) of 33 sampled patients during a surgical procedure.

2. The surgical consent did not match the actual procedure done for one of 33 sampled patients (N205).

3. There was no documentation of the surgeon's informed consent prior to doing the procedure on one of 33 sampled patients (Patient 303).

The cumulative effects of these systemic problems resulted in the hospital's inability to provide patient care in a safe manner.

Based on interview, and record review, the hospital failed to ensure surgical services policy and procedure and AORN (Association of Operating Room Nurses) guidelines for instrument count were followed and implemented when an endocatch bag ( EB -a flexible, disposable specimen bag #10 measuring 4"x 5" used to obtain specimens- tissue) was retained in the abdominal body cavity of Patient N400 following a laparoscopic left oophorectomy (surgical procedure to remove the left ovary) and salpingectomy (surgery to remove the fallopian tubes) on 9/8/21.


This failure resulted in Patient N400 being returned back to the operating room less than 2 hours after the first surgical procedure on 9/8/21 to remove a retained EB, placing the patient at risk for increase pain, injury, and possible side effects from successive anesthesia use.


Findings:


During the review of the clinical record for Patient N400 on 11/3/21, the operative report (OR) dictated by Surgeon 1 (S1) dated 9/8/21 at 09:37 AM, indicated Patient N400 was scheduled for laparoscopic left oophorectomy and bilateral salpingectomy (removal of both fallopian tubes). The OR further indicated S1 during the surgical procedure was able to manipulate the patient's left ovary and a specimen tube in the #10 EB but when it was time to remove the #10 EB out of the abdominal cavity and out of the patient's body it got imbedded (caught) deep into the abdominal area making the removal difficult. SI then proceeded to introduce (push in) a much larger size EB #15 on top of the #10 EB and was able to remove and transfer the left ovary and specimen tube out from the # 10 EB to the #15 EB.


Further review of the record indicated, the OR by S1 dated 9/8/21 timestamped 11:00 AM (less than 2 hours after the first surgical procedure) indicated Patient N400 was returned to the operating room after a verbal consent was obtained to remove a retained foreign object (RFO) identified as the #10 EB.


The AORN Guidelines for Perioperative Practice titled, "Retained Surgical Items" dated 2021 indicated, "3. Sharps and Miscellaneous Items. 3.1 Account for sharps and other miscellaneous items that are opened onto the sterile field during all procedures ...recommend accounting for sharps and miscellaneous items used ...in all procedures ...miscellaneous items are commonly miscounted and have been retained in patients ...The benefits of accounting for sharps and miscellaneous items outweigh the harms. Miscellaneous items retained during ...procedures ...have been reported to cause patient injury, including infection ...3.2 Perform counts of sharps and miscellaneous items: before the procedure ...when new items are added ...before closure of cavity ...when wound closure begins ...any time a discrepancy is suspected ...3.3. Sharps and miscellaneous items should be viewed concurrently by two individuals, one of whom should be the RN circulator, and counted audibly."



During an interview and concurrent record review on 11/3/21 at 3:14 PM, the Perioperative Services Director (PSD) indicated the EB is not an accountable miscellaneous item because it is a large item, disposable, and it goes into the body and comes out as one piece. The PSD further indicated, in the case of PN400, S1 elected to alter the device by cutting the EB into pieces and the circulating nurse (CN) was not made aware. The PSD reviewed the hospital policy and AORN ( Association of operating room nurses) guidelines for miscellaneous surgical items and concurred it was not followed and should have been.


During an interview on 11/3/21 at 4:39 PM, the CN indicated being not informed by S1 when the #10 EB was cut into pieces during the surgical procedure of PN400 on 9/8/21.


The hospital policy titled, "Sponge, Sharps, and Instrument Counts" revised 2/1/13 indicated, "A. General Considerations 1. Sponge, sharp, and miscellaneous item counts must be performed in any circumstance where these items are opened for a procedure ...6. Sharps and miscellaneous items with potential for being retained in a surgical wound should be counted on all procedures ...13. The OR team may be more vulnerable to distraction in certain instances. Heightened awareness (situational awareness) will be emphasized in situations where the risk of retained items is greater due to the nature of the procedure, i.e., emergency procedures, unexpected change in intended procedure or patient condition, patient obesity, multiple surgical teams, shift changes, staff member inexperience. B. Frequency of Sponge and Sharps Counts 1. Sharps (including miscellaneous items) and sponge counts are performed at the following times ...D. Procedure for Sponge, Sharps, and Instrument Counts ...3. All sponges, sharps and instruments added to the operative field during surgery ...are counted together and out loud and recorded immediately by the circulating nurse ...13. The circulating nurse is responsible for: a. Recording the count on the count worksheet or on the grease board. b. Recording the result of the final counts on the Intraoperative Record. c. Informing surgeon and team count results ... F. Documentation ...2. The documentation of counts should include ...a. Types of counts (i.e., sponges, sharps, instruments, miscellaneous items) as well as the number of counts must be included in either hospital-approved paper or electronic documentation ..."


Review of the hospital document "Applied Medical Inzii Universal Retrieval System" undated, indicated in part, " ...Care should be taken to avoid contact of the bag with sharp instruments, cutting devices ...Do not cut the bag cord prior to removal from port site."



During an interview on 11/4/21 at 9:09 AM, S1 acknowledged and concurred the hospital policy related to surgical items count was not followed when the #10 EB was retained in Patient N400's abdominal area. S1 further acknowledged forgetting to retrieve the #10 EB after removing the #15 EB out of Patient N400's abdominal area when the first surgical procedure was done on 9/8/21.

Based on interview and record review, the facility failed to follow their policy and procedure when:

1. The surgical consent did not match the actual procedure done for one of 33 sampled patients (N205).

2. There was no documentation of the surgeon's informed consent prior to doing the procedure on one of 33 sampled patients (Patient 303).

These facility failures have the potential to place the patients at risk of not providing them the right to make informed decisions about their surgical procedures or treatments.

Findings:

1. During a concurrent interview and record review on 11/3/21, at 3:48 p.m., with the labor and delivery manager (Peri-OpD), Patient N 205's clinical record was reviewed. The clinical record indicated Patient N 205 had a cesarean section (a surgical procedure to deliver a baby through the mother's abdomen) and bilateral tubal ligation (a surgical procedure for female sterilization in order to prevent pregnancy, where the surgeon ties and cuts the fallopian tubes) on 10/9/21 at 7:26 p.m. The surgical consent dated 10/9/21 indicated in part ... "Your physician has recommended the following operation or procedure with appropriate sedation/anesthesia: Cesarean Section." The Peri-OpD acknowledged the bilateral tubal ligation was not documented on the facility's surgical consent form. The Peri-OpD further acknowledged the consent was not complete and did not match the procedure performed.

During a review of the facility's policy and procedure titled "Consent and Informed Consent", dated 4/2018, indicated in part ... "Informed consent must be obtained for treatments/procedures that are complex in that they involve material risks that are not commonly understood. Typically, informed consent must be obtained for ...i. all treatments/procedures/services performed in the: 1. Operating room ...Documentation: 1. A document (H&P or progress note) shall be in the patient's permanent medical record prior to the procedure/treatment identifying that the procedures, alternatives, risks, and questions have been discussed with the patient or the patient's legal representative ...2. Consent to surgery or special procedure form: a. the consent should include: ii. The medical terminology for the procedure (without abbreviation) and the type of anesthesia to be used if applicable."


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2. The facility's policy and procedure titled "Consent and Informed Consent", dated 6/2/21, in part F indicated "Informed consent must be obtained for treatments/procedures that are complex in that they involve material risks that are not commonly understood. Typically, informed consent must be obtained for all treatments/procedures/services performed in the : iv. The insertion of chest tubes, central lines, and PICC lines including those inserted at the bedside ...Documentation: 1. A document (H&P or progress note) shall be in the patient's permanent medical record prior to the procedure/treatment identifying that the procedures, alternatives, risks, and questions have been discussed with the patient or the patient's legal representative. The topics that must be addressed in the informed consent discussion are: ii. " Potential benefits, risks, or side effects of the procedure, including potential problems that might occur during recuperation ...iv. Reasonable alternatives and the relevant risks, benefits and side effects to such alternatives ..."

During a review of Patient 303's central line procedure note, dated 10/21/21 and concurrent interview with administrator (Admin 2) on 11/3/21 at 3:45 p.m., the note did not contain any documentation that the patient was provided with the potential benefits, risks, or side effects of the procedure, alternatives ... Admin 2 acknowledged this and agreed that the procedural note needed to have documentation regarding the informed consent discussion that took place before procedure however there was no documentation of such in this note or anywhere in the clinical record for this patient.